Keeping track of data, development reports and other important documents for a given project for potential future need is always a concern for companies. Individuals working on a project may change; some will leave for other opportunities, and individual’s memories sometimes lapse. Regardless, there should be some type of centralized file system that is maintained within a company to ensure that such changes do not impact retention and traceability of information.

While there are a variety of documentation systems available to store this information, one question that is often raised is for how long should this project information such as data files, reports, memos, etc. be retained?

Individual companies generally have their own document retention policies. The following is what the US Food and Drug Administration (US FDA) and European Medicines Agency (EMA) recommend.

US FDA

A sponsor shall retain the records and reports for two (2_ years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until two (2) years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.57

EMA

For clinical trials conducted under Directive 2001/20/EC, the retention time is at least five (5) years after completion (Directive 2005/28/EC). For all trials in which the clinical trial data are used to support a marketing authorization (including Pediatric Use Marketing Authorizations under Regulation 1901/2006), Directive 2003/63/EC (amending Directive 2001/83/EC) states that essential documents should be retained for at least fifteen (15) years after completion or discontinuation of the trial or at least two (2) years after the granting of the last marketing authorization in the European Union (when there are no pending or contemplated marketing applications in the EU) or for at least two (2) years after formal discontinuation of clinical development of the investigational product, whatever is the longest. Directive 2003/63/EC (amending Directive 2001/83/EC) also states that “the sponsor or other owner of the data shall retain some of the documentation pertaining to the trial for as long as the product is authorized. This documentation shall include the protocol (…), standard operating procedures, all written opinions on the protocol and procedures, the investigator’s brochure, case report forms on each trial subject, final report and audit certificate(s), if available. The final report shall also be retained by the sponsor or subsequent owner, for five (5) years after the medicinal product is no longer authorized. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file-paper/electronic_en.pdf

Some additional information on document retention can be found in the International Conference on Harmonization Guidance for Industry, Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients which states that all production, control, and distribution records should be retained for at least one (1) year after the expiry date of the batch. For active pharmaceutical ingredients with retest dates, records should be retained for at least three (3) years after the batch is completely distributed.
Additional information on sample and document retention can be found in the United States Code of Federal Regulation (CFR) Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals. The regulations regarding retention samples of test articles can be found in CFR Title 21 Sections 320.38 and 320.63. Section 211.170 addresses Reserve Samples:

1. An appropriately identified reserve sample that is representative of each lot in each shipment of each active ingredient shall be retained. The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications, except for sterility and pyrogen testing. The retention time is as follows: (1) For an active ingredient in a drug product other than those described in paragraphs (a) (2) and (3) of this section, the reserve sample shall be retained for one (1) year after the expiration date of the last lot of the drug product containing the active ingredient. (2) For an active ingredient in a radioactive drug product, except for nonradioactive reagent kits, the reserve sample shall be retained for: (i) three (3) months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is thirty (30) days or less; or (ii) Six (6) months after the expiration date of the last lot of the drug product containing the active ingredient if the expiration dating period of the drug product is more than thirty (30) days. (3) For an active ingredient in an Over-the-Counter (OTC) drug product that is exempt from bearing an expiration date under § 211.137, the reserve sample shall be retained for three (3) years after distribution of the last lot of the drug product containing the active ingredient.
2. An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample consists of at least twice the quantity necessary to perform all the required tests, except those for sterility and pyrogens. Except for those for drug products described in paragraph (b)(2) of this section, reserve samples from representative sample lots or batches selected by acceptable statistical procedures shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of the reserve sample. Any evidence of reserve sample deterioration shall be investigated in accordance with § 211.192. The results of the examination shall be recorded and maintained with other stability data on the drug product. Reserve samples of compressed medical gases need not be retained. The retention time is as follows: (1) For a drug product other than those described in paragraphs (b) (2) and (3) of this section, the reserve sample shall be retained for one (1) year after the expiration date of the drug product.,(2) For a radioactive drug product, except for nonradioactive reagent kits, the reserve sample shall be retained for: (i) Three (3) months after the expiration date of the drug product if the expiration dating period of the drug product is thirty (30) days or less; or (ii) Six (6) months after the expiration date of the drug product if the expiration dating period of the drug product is more than thirty (30) days. (3) For an OTC drug product that is exempt for bearing an expiration date under § 211.137, the reserve sample must be retained for three (3) years after the lot or batch of drug product is distributed. [48 FR 13025, Mar. 29, 1983, as amended at 60 FR 4091, Jan. 20, 1995]